Law360, New York (May 28, 2010) --
Finding that NovartisPharmaceutical Corp. failed to come clean about consumer ads for its controversial Aredia and Zometa drugs, a federal judge has granted plaintiffs in the multidistrict litigation additional discovery, potentially aiding allegations that Novartis downplayed the dangers associated with the bone cancer drugs.
On Thursday, Magistrate Judge Joe Brown of the Middle District of Tennessee granted the plaintiffs’ steering committee further discovery to determine the extent Novartis advertised Aredia and Zometa to its consumers, a practice the defendant had expressly denied, but the court declined to impose the hefty sanctions plaintiffs’ sought.
Unconvinced by claims that Novartis deliberately deceived the court about the magazine advertisements in order to bolster its defense, Judge Brown refused to grant the plaintiffs $550,000 in sanctions but did tag Novartis with all the additional discovery costs and motions practice on the issue.
While the court didn’t see evidence of the fraud alleged by plaintiffs, Judge Brown rejected Novartis’ effort to draw a distinction between advertising for patients and consumers, and faulted the drugmaker for keeping mum about its dealings with the third-party advertising vendor.
The discovery scuffle concerns Novartis’ repeated claim that it did not advertise Aredia and Zometa directly to consumers, an assertion contradicted by advertisements that appeared in CURE magazine, according to the ruling.
After first conceding that it did advertise the drugs, the defendant amended its answer to a complaint in one of the bellwether cases in order to specifically deny that the drug was advertised to anyone other than physicians, a claim that has now been exploded.
Judge Brown also “strongly urged” Novartis to correct any answers and responses to discovery requests that specifically deny direct-to-consumer advertising of Zometa and Aredia.
Plaintiffs’ attorney John J. Vecchione applauded the court’s decision and said additional revelations about the advertising campaign could undermine Novartis’ “learned intermediary” defense.
Under that defense, Novartis claims that it informed doctors about the potential effects of the drugs, combating plaintiffs’ allegations that the defendant did not warn about the risks of jawbone deterioration, Vecchione said.
“The plaintiffs regret having to seek sanctions over this matter, but we are pleased that the court’s decision allows us to move forward and get the information we need,” Vecchione said.
The motion for sanctions spotlighted the grave implications of Novartis’ deception, claiming that years of false testimony “threaten the very legitimacy of this proceeding” and reveal Novartis’ will to hide the truth of its Aredia and Zometa marketing.
The two bone cancer drugs are the focus of the MDL as well as a mass tort proceeding in New Jersey, both of which allege Novartis failed to warn about the risks of osteonecrosis of the jaw, or ONJ.
Novartis maintains that it adequately conveyed the information known at the time. Prior to 2003, it did not have a duty to warn because no cases of ONJ had been reported. It also claimed that once cases were reported, it took the proper steps by conducting an investigation and making changes to its labels.
While the first wave of cases in the MDL are approaching trial, in October, a state jury in Montana awarded $3.2 million in damages in a similar case over Zometa in what was considered a bellwether trial for the MDL.
Representatives for Novartis could not be reached for comment Friday.
The plaintiffs steering committee is being represented by Valad & Vecchione PLLC.
Novartis is being represented by Hollingsworth LLP.
The MDL is In re: Aredia and Zometa Products Liability Litigation, case number 06-md-01760, in the U.S. District Court for the Middle District of Tennessee.
--Additional reporting by Mike Cherney